Expanded US approval for Fetroja

The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Fetroja (cefiderocol), submitted by Japanese pharma major Shionogi (TYO: 4507), whose share closed down 2.3% at 5,735 yen today.

The new indication is for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens.

“Antimicrobial resistance is a major global health concern, and there is a clear need for new treatments such as Fetroja to give clinicians more options to fight life-threatening infections caused by Gram-negative pathogens,” said Akira Kato, president and chief executive at Shionogi, adding: “This milestone represents Shionogi’s long-standing and unwavering commitment to constantly fight evolving infectious diseases in an era realizing significant unmet needs.”